Ecg patch and methods of use

ABSTRACT

A compact integrated patch may be used to collect physiological data. The patch may be wireless. The patch may be utilized in everyday life as well as in clinical environments. Data acquired by the patch and/or external devices may be interpreted and/or be utilized by healthcare professionals and/or computer algorithms (e.g., third party applications). Data acquired by the patch may be interpreted and be presented for viewing to healthcare professionals and/or ordinary users.

CROSS-REFERENCE

This application is a continuation of U.S. application Ser. No.14/814,436, filed Jul. 30, 2015, which claims the benefit of U.S.Provisional Application No. 62/031,079, filed Jul. 30, 2014, and U.S.Provisional Application No. 62/186,277, filed Jun. 29, 2015, each ofwhich applications is incorporated herein by reference.

BACKGROUND OF THE INVENTION

Monitoring physiological conditions of the human body has been animportant component of health care. Although the monitoring can beperformed periodically by health care professionals, increasingly thetask is being handled by electronics that connect the patient to acomputerized system for autonomous data storage, presentation andretrieval. Moreover, autonomous monitoring for collection ofphysiological data is becoming an important part of everyday life withthe advent of the quantified-self movement.

Most sensors used in monitoring physically contact the body, requiring amethod for connecting sensors to the rest of the electronic system.While simple sensors (e.g., a wrist monitor) have been used to collectsimple data that tracks a person's physical activity or sleep patterns,cumbersome wires distributed throughout the body have traditionally beennecessary to collect more meaningful physiological data.

SUMMARY OF THE INVENTION

Embodiments disclosed herein provide systems and methods for monitoringa user. A compact integrated patch may be used to collect physiologicaldata. The patch may be wireless. The patch may be utilized in everydaylife as well as in clinical environments. A quality of data acquiredusing the patch may depend on both a location of the patch on a user anorientation of the patch relative to a longitudinal axis of the user.The patch may comprise at most two instrumentation amplifiers. The patchmay communicate with one or more external devices via wired and/orwireless connection. Data acquired by the patch and/or external devicesmay be interpreted and/or be utilized by healthcare professionals and/orcomputer algorithms (e.g., third party applications). Data acquired bythe patch may be interpreted and be presented for viewing to healthcareprofessionals and/or ordinary users. The patch may communicate to a user(e.g., send an alert) based on the interpreted data.

Thus, in one aspect, an integrated patch is provided. The patchcomprises: a base comprising two or more electrodes configured to gatherinformation; a cover coupled to the base, wherein the cover comprisesone or more indicators associated with a preferred placement ororientation of the patch; an electronic module in communication with thetwo or more electrodes, wherein the electronic module is housed betweenthe base and the cover; and a radio in communication with the electronicmodule configured to wirelessly transmit or receive data.

In some embodiments, the base is circular and has a diameter equal to orless than 5 inches. In some embodiments, the base comprises fourelectrodes. In some embodiments, wherein each of the four electrodescorrespond to at least a right arm (RA), left arm (LA), right leg (RL),and left leg (LL) electrode and are configured to gather informationsufficient to generate at least three limb leads. In some embodiments,the four electrodes are arranged in a rectangular orientation. In someembodiments, the base further comprises a fifth electrode, wherein thefifth electrode is configured to reduce a noise of acquired signals. Insome embodiments, the fifth electrode is located within at least 1.5inches of the RL electrode. In some embodiments, the indicator is asymbol, marking, sign, or shape. In some embodiments, the indicatorcomprises an LED. In some embodiments, the indicator is associated withthe preferred placement or orientation of the patch on a user. In someembodiments, the indicator responds to a correct placement of the patchon a user. In some embodiments, the preferred placement is near a centerof a chest or near an upper right chest of a human being. In someembodiments, the patch is configured to communicate with one or moreexternal devices via the radio. In some embodiments, the one or moreexternal devices comprise cell phones, tablet, PDAs, or fitnesstrackers. In some embodiments, the radio comprises a triple mode hybridradio able to communicate using Wi-Fi, Medical band, and ultra widebandbandwidths. In some embodiments, the base and the cover are made of thesame material. In some embodiments, the base and the cover are made ofsilicone. In some embodiments, the patch further comprises a spacerconfigured to separate the base from the cover, wherein the spacerdefines a space in which the electronic module is to be located in. Insome embodiments, the spacer comprises an electrically insulatingmaterial. In some embodiments, the spacer prevents signal leakagebetween the electrodes. In some embodiments, the spacer comprises ashock absorbing material configured to absorb or redirect externalforces. In some embodiments, the cover is removably coupled to the base.In some embodiments, the electronic module is removably coupled to thebase. In some embodiments, the patch comprises one or more processorsindividually or collectively configured to analyze or process gatheredinformation. In some embodiments, the patch comprises a visual,auditory, or haptic alert system configured to send an alert to a userbased on gathered information.

In another aspect, an integrated patch is provided. The patch comprises:a base comprising two or more electrodes configured to measure avoltage; a cover coupled to the base; an electronic module incommunication with the two or more electrodes, wherein the electronicmodule is housed between the base and the cover and comprises one ormore instrumentation amplifiers configured to amplify a differencebetween voltages measured from two different electrodes; and a radio incommunication with the electronic module configured to wirelesslytransmit or receive data.

In some embodiments, the base is circular and has a diameter equal to orless than 5 inches. In some embodiments, the base comprises fourelectrodes. In some embodiments, each of the four electrodes correspondto at least a right arm (RA), left arm (LA), right leg (RL), and leftleg (LL) electrode and are configured to gather information sufficientto generate at least three limb leads. In some embodiments, the fourelectrodes are arranged in a rectangular orientation. In someembodiments, the base further comprises a fifth electrode, wherein thefifth electrode is configured to reduce a noise of acquired signals. Insome embodiments, the fifth electrode is located within at least 1.5inches of the RL electrode. In some embodiments, the patch comprises atmost two instrumentation amplifiers. In some embodiments, a firstinstrumentation amplifier amplifies a difference between voltagemeasured by the LA electrode and the LL electrode and the secondinstrumentation amplifier amplifies a difference between voltagemeasured by the RA electrode and the LL electrode. In some embodiments,a first instrumentation amplifier amplifies a difference between voltagemeasured by the LA electrode and the RA electrode and the secondinstrumentation amplifier amplifies a difference between voltagemeasured by the RA electrode and the LL electrode. In some embodiments,the patch is configured to communicate with one or more external devicesvia the radio. In some embodiments, the one or more external devicescomprise cell phones, tablet, PDAs, or fitness trackers. In someembodiments, the radio comprises a triple mode hybrid radio able tocommunicate using Wi-Fi, Medical band, and ultra wideband bandwidths. Insome embodiments, the base and the cover are made of the same material.In some embodiments, the base and the cover are made of silicone. Insome embodiments, the patch further comprises a spacer configured toseparate the base from the cover, wherein the spacer defines a space inwhich the electronic module is to be located in. In some embodiments,the spacer comprises an electrically insulating material. In someembodiments, the spacer prevents signal leakage between the electrodes.In some embodiments, the spacer comprises a shock absorbing materialconfigured to absorb or redirect external forces. In some embodiments,the cover is removably coupled to the base. In some embodiments, theelectronic module is removably coupled to the base. In some embodiments,the patch comprises one or more processors individually or collectivelyconfigured to analyze or process gathered information. In someembodiments, the patch comprises a visual, auditory, or haptic alertsystem configured to send an alert to a user based on gatheredinformation.

In another aspect, an integrated patch is provided. The patch comprises:a base comprising two or more electrodes configured to gatherinformation; a cover coupled to the base; one or more ports configuredto communicate with one or more removably attachable electrodes; anelectronic module in communication with the two or more electrodes,wherein the electronic module is housed between the base and the cover;and a radio in communication with the electronic module configured towirelessly transmit or receive data.

In some embodiments, the base is circular and has a diameter equal to orless than 5 inches. In some embodiments, the base comprises fourelectrodes. In some embodiments, each of the four electrodes correspondto at least a right arm (RA), left arm (LA), right leg (RL), and leftleg (LL) electrode and are configured to gather information sufficientto generate at least three limb leads. In some embodiments, the fourelectrodes are arranged in a rectangular orientation. In someembodiments, the base further comprises a fifth electrode, wherein thefifth electrode is configured to reduce a noise of acquired signals. Insome embodiments, the fifth electrode is located within at least 1.5inches of the RL electrode. In some embodiments, the one or more otherelectrodes are configured to gather information regarding precordialleads. In some embodiments, the patch is configured to communicate withone or more external devices via the radio. In some embodiments, the oneor more external devices comprise cell phones, tablet, PDAs, or fitnesstrackers. In some embodiments, the radio comprises a triple mode hybridradio able to communicate using Wi-Fi, Medical band, and ultra widebandbandwidths. In some embodiments, the base and the cover are made of thesame material. In some embodiments, the base and the cover are made ofsilicone. In some embodiments, the patch further comprises a spacerconfigured to separate the base from the cover, wherein the spacerdefines a space in which the electronic module is to be located in. Insome embodiments, the spacer comprises an electrically insulatingmaterial. In some embodiments, the spacer prevents signal leakagebetween the electrodes. In some embodiments, the spacer comprises ashock absorbing material configured to absorb or redirect externalforces. In some embodiments, the cover is removably coupled to the base.In some embodiments, the electronic module is removably coupled to thebase. In some embodiments, the patch comprises one or more processorsindividually or collectively configured to analyze or process gatheredinformation. In some embodiments, the patch comprises a visual,auditory, or haptic alert system configured to send an alert to a userbased on gathered information.

In another aspect, an integrated patch is provided. The patch comprises:a base comprising two or more electrodes configured to gatherinformation; a cover coupled to the base; one or more additional typesof sensors configured to gather other information; an electronic modulein communication with the two or more electrodes, wherein the electronicmodule is housed between the base and the cover; and a radio incommunication with the electronic module configured to wirelesslytransmit or receive data.

In some embodiments, the base is circular and has a diameter equal to orless than 5 inches. In some embodiments, the base comprises fourelectrodes. In some embodiments, each of the four electrodes correspondto at least a right arm (RA), left arm (LA), right leg (RL), and leftleg (LL) electrode and are configured to gather information sufficientto generate at least three limb leads. In some embodiments, the fourelectrodes are arranged in a rectangular orientation. In someembodiments, the base further comprises a fifth electrode, wherein thefifth electrode is configured to reduce a noise of acquired signals. Insome embodiments, the fifth electrode is located within at least 1.5inches of the RL electrode. In some embodiments, the one or moreadditional types of sensors comprise sensors able to gather informationregarding heart rate or respiration of a user. In some embodiments, theone or more additional types of sensors comprise sensors able to gatherinformation regarding ambulatory data of a user. In some embodiments,the one or more additional types of sensors comprise sensors able togather information regarding hydration, temperature, SpO2, or bloodpressure of a user. In some embodiments, the one or more additionaltypes of sensors comprise sensors able to gather information regardingacceleration, audio, vision, or pressure of an environment around thepatch. In some embodiments, the patch is configured to communicate withone or more external devices via the radio. In some embodiments, the oneor more external devices comprise cell phones, tablet, PDAs, or fitnesstrackers. In some embodiments, the radio comprises a triple mode hybridradio able to communicate using Wi-Fi, Medical band, and ultra widebandbandwidths. In some embodiments, the base and the cover are made of thesame material. In some embodiments, the base and the cover are made ofsilicone. In some embodiments, the patch further comprises a spacerconfigured to separate the base from the cover, wherein the spacerdefines a space in which the electronic module is to be located in. Insome embodiments, the spacer comprises an electrically insulatingmaterial. In some embodiments, the spacer prevents signal leakagebetween the electrodes. In some embodiments, the spacer comprises ashock absorbing material configured to absorb or redirect externalforces. In some embodiments, the cover is removably coupled to the base.In some embodiments, the electronic module is removably coupled to thebase. In some embodiments, the patch comprises one or more processorsindividually or collectively configured to analyze or process gatheredinformation. In some embodiments, the patch comprises a visual,auditory, or haptic alert system configured to send an alert to a userbased on gathered information.

In another aspect, a method of collecting physiological data isprovided. The method comprises: providing an integrated patchcomprising: a base comprising two or more electrodes configured togather information; a cover coupled to the base, wherein the covercomprises one or more indicators associated with a preferred placementor orientation of the patch; a radio configured to wirelessly transmitor receive data; and an electronic module comprising an ASIC housedbetween the base and the cover; and placing the patch on a user based onthe one or more indicators; and collecting information from the patch.

In another aspect, a method of amplifying a differential signal betweentwo input signal voltages is provided. The method comprises: providing apatch comprising: a base comprising two or more electrodes configured tomeasure a voltage; a cover coupled to the base; a radio configured towirelessly transmit or receive data; and an electronic modulecomprising: an ASIC housed between the base and the cover; and one ormore instrument amplifiers configured to amplify a difference betweenvoltages measured from two different electrodes; measuring a voltagefrom the two or more electrodes; and amplifying a difference between themeasured voltages.

In another aspect, a system for acquiring physiological signals isprovided. The system comprises: a wireless integrated patch; aninstruction regarding a recommended placement and orientation of thepatch.

In some embodiments, the recommended placement comprises at least twodifferent locations on the human body and wherein an orientation of thepatch is different depending on the different locations.

In another aspect, a method of placing a wireless integrated patch on auser is provided. The method comprises: matching a placement andorientation of the patch to a provided figure; and placing the patchaccording to the provided figure.

In another aspect, a method of collecting physiological data isprovided. The method comprises: providing any of the aforementionedintegrated patch; placing the patch on a user at a preferred location orin a preferred orientation; and collecting information from the patch.

In some embodiments, the method further comprises sending the collectedinformation to an external device for processing of the collectedinformation. In some embodiments, the method further comprises sendingan alert to the user based on the processed information.

In another aspect, an integrated wireless patch is presented. The patchcomprises: a base, wherein the base comprises at least four electrodes;a cover; an electronic module housed between the base and the cover,wherein the electronic module comprises at most two instrumentationamplifiers, and wherein the patch is capable of generating three limbleads.

In another aspect, an integrated wireless patch is presented. The patchcomprises a base, wherein the base is at most 4 inches in diameter andcomprises four electrodes arranged in a square configuration, whereinthe four electrodes correspond to

In another aspect, a method of placing an integrated wireless patch ispresented. The method comprises placing a patch comprising two or moreelectrodes.

It shall be understood that different aspects of the invention can beappreciated individually, collectively, or in combination with eachother. Various aspects of the invention described herein may be appliedto any of the particular applications set forth below. Other objects andfeatures of the present invention will become apparent by a review ofthe specification, claims, and appended figures.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by referencein their entirety.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 illustrates a dissembled patch, in accordance with embodiments.

FIG. 2 illustrates a relative placement and orientation of the patch, inaccordance with embodiments.

FIG. 3 illustrates a method of collecting physiological data, inaccordance with embodiments.

FIG. 4 illustrates patch in communication with clinical monitor viawireless link, in accordance with embodiments.

FIG. 5 illustrates a single ended amplification of signal fromelectrodes.

FIG. 6 illustrates generation of limb leads using three IAs.

FIG. 7 illustrates acquisition of three lead signals with two IAs, inaccordance with embodiments.

FIG. 8 illustrates an adaptor receiving signals and subsequent output toECG monitor, in accordance with embodiments

FIG. 9 illustrates an alternative set up for acquisition of three leadsignals with two IAs, in accordance with embodiments.

FIG. 10 illustrates a patch having a port for connection to anelectrode, in accordance with embodiments.

FIG. 11 illustrates a patch connected to an electrode with a wireacquiring data regarding limb leads, augmented limb leads, andprecordial limb leads, in accordance with embodiments.

FIG. 12 illustrates an open patch platform communicating with otherdevices, in accordance with embodiments.

FIG. 13 illustrates wired and wireless patch systems, in accordance withembodiments.

FIG. 14 illustrates wireless patch/receiver systems for patientmonitoring, in accordance with embodiments.

FIG. 15 illustrates wireless patch/mobile device systems, in accordancewith embodiments.

FIG. 16 illustrates electronics for a patch, in accordance withembodiments.

FIG. 17 illustrates a wireless module of a patch, in accordance withembodiments.

FIG. 18 illustrates a foldable patch design, in accordance withembodiments.

FIG. 19 illustrates two different perspectives of a blown up view of apatch design, in accordance with embodiments.

FIG. 20 illustrates a working configuration of the patch design of FIG.19 from two different perspectives, in accordance with embodiments.

FIG. 21 illustrates a patch design, in accordance with embodiments.

FIG. 22 illustrates a measurement template that may be used for markingareas where snaps will go.

FIG. 23 illustrates a depiction that may be used for inserting a prongsnap.

FIG. 24 depicts a first illustration showing wires soldered to a bottomassembly, a second illustration showing a wire cover label, and a thirdillustration showing the wire cover affixed to the bottom assembly.

FIG. 25 illustrates a general view and detailed view of wire layout tothe HMI module.

FIG. 26 illustrates HMI module attached to the bottom assembly in afirst illustration and switch, led, and battery attached to the bottomassembly in addition to the HMI module in a second illustration.

FIG. 27 illustrates a patch label that may be placed on the patch.

DETAILED DESCRIPTION OF THE INVENTION

Provided herein are patches comprising a base, a cover, and anelectronic module located therebetween. The patch may be used foracquisition of physiological data. For example, the patch may be usedfor acquisition of data relating to electrocardiography (ECG).

FIG. 1 illustrates components of a patch, in accordance withembodiments. The patch may comprise at least a base 102, a cover 104,and an electronic module 106. The electronic module may be locatedbetween the base and the cover (e.g., sandwiched between the base andthe cover).

The base 102 may be configured to come into contact with a surface(e.g., skin) of a user. While a circular base is illustrated in FIG. 1,the base may be of any shape, including circular, semi-circular, oval,rectangular, polygonal, or of any arbitrary shape. The base may be madeof any material including synthetic polymers such as thermoplastics,thermosets, elastomers, and synthetic fibers. The base may be inert. Thebase may be flexible or rigid. The base may be stretchable ornon-stretchable. The base may be compressible or non-compressible. Insome instances, the base may be made of a biocompatible material, suchas silicone. In some instances, the base may be a made of a shapeconforming material that conforms to a shape of the user. The base maybe of any size. In some instances, the base may be less than about 2inches, 2.5 inches, 3 inches, 3.5 inches, 4 inches, 4.5 inches, or 5inches, 5.5 inches, 6 inches, 7 inches, or 8 inches in length ordiameter. In some instances, the base may be greater than about 2inches, 2.5 inches, 3 inches, 3.5 inches, 4 inches, 4.5 inches, 5inches, 5.5 inches, 6 inches, 7 inches, or 8 inches in length ordiameter. In some instances, the base may be about 3.5 inches in lengthor diameter.

The base may comprise four electrodes 108, 110, 112, 114. In someinstances, the base may comprise one, two, three, four, five, six ormore electrodes. In some instances, the base may comprise no more thanone, two, three, four, five, or six electrodes. The electrodes may beintegrated into the base. The electrodes may be separate components fromthe base that are releasably or permanently coupled to the base. Asreferred to herein, a base comprising electrodes may refer to a base towhich electrodes are coupled to. For example, the four electrodes shownin FIG. 1 may be electrodes shown through openings or holes on the base.Each of the electrodes may be located equal to about or greater than0.25 inches, 0.5 inches, 0.75 inches, 1 inch, 1.25 inches, 1.5 inches,1.75 inches, or 2 inches away from the edge of the base. Each of theelectrodes may be located equal to about or less than 0.25 inches, 0.5inches, 0.75 inches, 1 inch, 1.25 inches, 1.5 inches, 1.75 inches, or 2inches away from the edge of the base.

The electrodes may be positioned relative to one another. For example,the electrodes may be located equal to or less than about 0.25 inches,0.5 inches, 0.75 inches, 1 inch, 1.25 inches, 1.5 inches, 2 inches, 2.25inches, 2.5 inches, 2.75 inches, or 3 inches from one another. Forexample, the electrodes may be located equal to or more than about 0.25inches, 0.5 inches, 0.75 inches, 1 inch, 1.25 inches, 1.5 inches, 2inches, 2.25 inches, 2.5 inches, 2.75 inches, or 3 inches from oneanother. For example, the electrodes may be located between about 0.25inches, 0.5 inches, 0.75 inches, 1 inch, 1.25 inches, 1.5 inches, 2inches, 2.25 inches, 2.5 inches, 2.75 inches, or 3 inches from oneanother. The electrodes may be spaced equidistant from one another. Theelectrodes may be radially spaced equidistant from one another. Forexample, for a base having N electrodes, the electrodes may be angularlyspaced 360/N degrees from each other. The electrodes may be angularlyspaced 45°, 60°, 90°, 120°, or 180° from one another measured from acenter of the base. In some instances, the electrodes may be arranged ina circular pattern or rectangular pattern. The electrodes may beradially symmetric about a line that bisects a center of the base. Eachof the electrodes may gather information (e.g., measure a voltage) fromthe location where it is placed. The information may be sent to anelectronic module, e.g., through conductive traces as further describedbelow.

For a base comprising four electrodes, each of the electrodes 108, 110,112, 114 may correspond to limb electrodes that are placed on a user inconventional ECG. For example, electrode 108 may correspond to a rightarm (RA) electrode, electrode 110 may correspond to a left arm (LA)electrode, electrode 112 may correspond to a right leg (RL) electrode,and electrode 114 may correspond to a left leg (LL) electrode as used ina conventional ECG monitor. Three limb leads (Lead I, Lead II, and LeadIII) and three augmented limb leads (aVR, aVL, and aVF) may becalculated according to conventional calculations using data (e.g.,voltage) acquired from the RA, LA, LL, and RL electrodes. In someinstances, the base may comprise a fifth electrode 116. The fifthelectrode may be utilized to further reduce noise of acquired signals(e.g., used as a second RL electrode). The fifth electrode may belocated about or within at least 0.25 inches, 0.5 inches, 0.75 inches, 1inch, 1.25 inches, or 1.5 inches of the RL electrode 114.

The base may further comprise cutouts. The cutouts may define a spacethrough which the electrodes may contact the user. The cutouts mayclosely trace or define a shape of the electrodes that were describedherein. In some instances, the cutouts can be surrounded by spiralcutouts. The spiral cutouts may provide flexibility between the base andthe skin of the user and may serve to reduce strain between the base andthe skin surface. In some embodiments, the cutouts of the base maycomprise adhesives that surround the cutouts. The adhesives may beconfigured to couple the patch to a skin of the user. The cutouts mayfurther be filled with a gel (e.g., electrode gel) that conducts anelectrical signal from a surface of the user. The electrode gel may beused in conjunction with the adhesive washers and the cutouts tofacilitate communication between the surface of the user and theelectrodes. In some instances, the base (e.g., and/or cover or spacer,further described herein) may comprise a removable layer. The removablelayer may provide a protective layer against the surrounding environment(e.g., dust, light, water, etc) during storage and/or prior toutilization of the patch. The removable layer may be configured to bepeeled off by a user prior to usage of the patch. For furtherdescription regarding, cutouts, spiral cutouts, adhesives, and gels,please refer to U.S. Pat. Nos. 8,628,020, 8,718,742, and U.S.Publication No. 2011/0028822 which are hereby incorporated by referencein their entirety.

In some instances, the patch may comprise a spacer. The spacer may bemade of any material including synthetic polymers such asthermoplastics, thermosets, elastomers, and synthetic fibers. The spacermay be inert. The spacer may be flexible or rigid. The spacer may bestretchable or non-stretchable. The spacer may be compressible ornon-compressible. The spacer may be coupled to the base and/or cover.The spacer may be configured to couple the base to the cover. In someinstances, the spacer may be configured to separate the base from thecover. The spacer may define a space in which an electronic module is tobe located within. In some instances, the spacer may comprise amid-layer that can house the electronic module. For example, FIG. 19illustrates a spacer 1906 that may house the electronic module 1908. Insome instances, the spacer may comprise a fold 1806, 1808, or 1810connecting the base and the cover which may be folded over, asillustrated in FIG. 18. In some instances, the spacer may comprise ahollow cylindrical column 118 configured to provide an empty spacebetween the base and the cover in which the electronic module may beplaced, as illustrated in FIG. 1. The spacer may be coupled to the baseand/or cover removably (e.g., with adhesives, lock on mechanism, etc) orpermanently. In some instances, the spacer may be coupled to the basepermanently and the spacer may be coupled to the cover removably, orvice versa. In some instances, the spacer may be integrated into thebase and/or cover (e.g., as a single mold). The spacer may comprise anelectrically insulating material. In some instances, the spacer mayprevent signal leakage between the electrodes. The spacer may comprise ashock absorbing material. The spacer may add a bit of thickness to keepthe electronic module from sticking out too far (e.g., into the cover).The spacer may provide protection to the electronic module. The spacermay absorb or redirect external forces such that the electronic moduleis protected from external forces. In some instances, the spacer may bemade of the same material as the base and/or the cover. For example, thespacer may be made of silicone.

The electronic module 106 may be coupled to the base. The electronicmodule may be in communication with one or more electrodes (e.g.,electrodes 108, 110, 112, 114, or 116). In some instances, theelectronic module may be in communication with each of the electrodes ofthe patch. In some instances, the electronic module may be directlycoupled to the base. For example, the electronic module may bemechanically or chemically fixed on top of the base. In some instances,the electronic module may be housed within the mid-layer (e.g., spacer)which is coupled to the base. The electronic module may comprise amulti-chip module or ASIC to integrate most of the needed functions intoa single module. The ASIC can be a single chip device. In someembodiments, additional components can be added to the ASIC as needed.For example, the electronic module may comprise additional componentssuch as sensors (e.g., accelerometers), microphones, batteries 119,sensor interfaces 120, radios 122, antennas 124, memory, etc.Alternatively or in addition, the aforementioned additional componentsmay be located elsewhere on the patch and the electronic module may bein communication with the additional components.

The radio 122 may enable the patch to communicate with other devicesthrough a wireless link. The radio may be configured to wirelesslytransmit and/or receive data. The radio may be configured to wirelesslytransmit data to external devices and/or receive data from the externaldevices. The radio may be a single-mode, dual-mode, triple-mode, orquad-mode radio. The radio may utilize any known bandwidth, e.g.,narrowband, wideband, ultra wideband, broadband, etc. The radio maycommunicate through Wi-Fi, Bluetooth, wireless usb, etc. In someinstances, the radio may be a triple-mode hybrid radio. The triple-modehybrid radio may utilize Wi-Fi, Medical band, and/or ultra widebandbandwidths. The triple-mode hybrid radio may seamlessly transitionbetween the three modes to maintain link integrity. The triple-modehybrid radio may select a lowest power option when more than one optionis available. Alternatively, the radio may be a single-mode or dual-moderadio. For example, the single-mode radio may utilize Wi-Fi. Forexample, the single-mode radio may utilize Medical band bandwidths. Forexample, the single-mode radio may utilize ultra wideband bandwidths.

The cover 104 may be configured to be coupled to the base. In someinstances, the cover may be coupled to the spacer. In some instances,the cover may be coupled to the base via the spacer. The cover may bemade of any material including synthetic polymers such asthermoplastics, thermosets, elastomers, and synthetic fibers. The covermay be inert. The cover may be flexible or rigid. The cover may bestretchable or non-stretchable. The cover may be compressible ornon-compressible. The cover, together with the base (e.g., and spacer)may provide an enclosure or a housing for the electronic module. Thehousing may provide protection and/or isolation to the electronic modulefrom the surrounding environment, e.g., water, dust, light, air, etc. Insome instances, the housing may be waterproof. While a circular cover isillustrated in FIG. 1, the cover may be of any shape, includingcircular, semi-circular, rectangular, polygonal, or of any arbitraryshape. In some instances, the base may be of the same or similar shapeas the base. The cover may be made of any material. In some instances,the cover may be made of a biocompatible material, such as silicone. Insome instances, the base may be a made of a shape conforming materialthat conforms to a shape of the electronic module. In some instances,the cover may be made of the same material as the base. In someinstances, the base and cover may be made of different materials.

The cover may be of any size. In some instances, the cover may be lessthan about 2 inches, 2.5 inches, 3 inches, 3.5 inches, 4 inches, 4.5inches, 5 inches, 5.5 inches, 6 inches, 7 inches, or 8 inches in lengthor diameter. In some instances, the cover may be greater than about 2inches, 2.5 inches, 3 inches, 3.5 inches, 4 inches, 4.5 inches, 5inches, 5.5 inches, 6 inches, 7 inches, or 8 inches in length ordiameter. In some instances, the cover may be about 3.5 inches in lengthor diameter. In some instances, the cover may be of the same size as thebase. In some instances, the cover may be about 5%, 10%, 15%, or 20%larger than the base. In some instances, both the base and cover may bemade of silicone. In some instances, the base, cover, and spacer may bemade of silicone. For example, the base, cover, and spacer may be madefrom medical or food grade silicone.

The cover may comprise an input/output (I/O) used to communicateinformation from the patch to a user or a healthcare professional.Input/outputs include, but are not limited to, light emitting diodes(LEDs), switches, or any other suitable indicator or actuator. In someinstances, the cover may comprise a display. For example, the patch maycomprise a display screen (e.g., LED or LCD screen). The display screenmay be a touch screen. The display may display the various monitoredphysiological parameters. In some instances, devices coupled to thepatch (e.g., physical monitoring device, mobile devices, computer,tablet, etc) may display the various monitored physiological parameters.

The cover may be configured to convey information to a user of the patchor to a healthcare professional. The cover may comprise one or moreindicators 126. The indicators may be markings such as a sign, symbol,or figure (e.g., X sign or + sign). The indicators may be a color. Forexample, a color may be used to indicate a functionality or capabilityof the patch. In some instances, the markings may signify a recommendedorientation of the patch or a placement of the patch with respect to theuser. In some instances, the one or more indicators may comprise theinput/output previously mentioned herein. For example, the cover maycomprise an LED. The LED may respond to (e.g., light up) being placed ona user in a correct orientation or on a correct position on the user. Acorrect orientation and/or placement may be important for obtainingmeaningful information from the patch, as further described below.

The patch may be utilized in acquiring various data. For example, thepatch may acquire ECG data, e.g., 6-wave ECG data. The patch may acquireheart rate and respiration data. The patch may acquire data regardingacceleration, hydration, temperature, SpO2, and/or blood pressure. Thepatch may acquire data related to ambulatory data. The patch may acquiredata regarding a motion and/or location of a user. The patch may acquiredata related to auditory, visual, or barometric data of the user or anenvironment around the user. In some instances, patch may be used forlead off detection.

In some instances, a single patch may be provided for acquiring thevarious aforementioned data. In some instances, the patch may provide amodular platform on which additional sensor interfaces may be added orsubtracted on depending on a user's need. In some instances, differentpatches with different functionalities and sensor interfaces may beprovided. In some instances, the patch may comprise swappable parts(e.g., electronic modules) which may be swapped out depending on auser's needs. In some instances, components of the patch may besupplemented and/or upgraded for additional capabilities (e.g.,additional sensors). The patch as described herein may compriseadditional free space in which additional sensor interfaces may be addedor taken away for acquisition of additional data. The patch as describedherein may comprise modular components (e.g., sensors, swappable parts)that may be swapped in and out of the patch to give the patch differentfunctionalities depending on a user's needs.

FIG. 2 illustrates an orientation and placement of patch that generatesmeaningful, or high quality data, in accordance with embodiments. Highquality data as used herein may refer to precise, accurate,interpretable, and/or reproducible data. A first patch 202 and a secondpatch 204 may both illustrate the patch described in FIG. 1 placed attwo different locations on a human body. The first patch shows a markingimitating an addition sign on the cover while the second patch shows amarking imitating a multiplication sign on the cover. The second patchmay show a rotated first patch that is placed on a different location onthe user 206. A single patch may be sufficient to collect high qualitydata. A placement of the patch on the human body may be of importancefor obtaining a high quality data. For example, high quality data may beobtained when the patch is placed near the upper left chest (e.g.,location of patch 202) or at a center of the chest (e.g., location ofpatch 204). A patch placed near a center of the chest may be centeredover the sternum. A patch placed near a center of the chest may becentered over the sternum and no lower than the xiphoid process.

An orientation of the patch may be of importance for obtaining highquality data. For example, when the patch is placed near the upper leftchest, electrodes arranged in a normal orientation (e.g., relative to alongitudinal axis of the user) may enable acquisition of high qualitydata. A normal orientation as used herein may refer to an arrangement ofelectrodes as illustrated in FIG. 1. For example, a normal orientationof electrodes may be arranged in a rectangular shape relative to alongitudinal axis of the user. Electrodes arranged in a normalorientation may have a virtual line going through a LA electrode and aRA electrode be substantially perpendicular to a longitudinal axis ofthe user. Electrodes arranged in a normal orientation may have a virtualline going through a LL electrode and a RL electrode be substantiallyperpendicular to a longitudinal axis of the user. Electrodes arranged ina normal orientation may have a virtual line going through a LA and a LLelectrode be substantially parallel to a longitudinal axis of the user.Electrodes arranged in a normal orientation may have a virtual linegoing through a RA and a RL electrode be substantially parallel to alongitudinal axis of the user. The configuration of electrodes asillustrated in FIG. 1 (e.g., relative to a longitudinal axis of theuser) may enable acquisition of high quality data when the patch isplaced near the upper left chest. The configuration of electrodes asillustrated in FIG. 1 may enable acquisition of high quality data whenthe patch is placed near a center of the chest.

In some instances, a different orientation of the patch may be preferredrelative to a longitudinal axis of the user. For example, electrodesarranged in a tilted orientation (e.g., relative to a longitudinal axisof the user) may enable acquisition of high quality data. A tiltedorientation as used herein may refer to an arrangement of electrodesthat is rotated about 15°, 30°, 45°, 60°, 75°, 90°, 120°, 150°, 180° ormore clockwise from the normal orientation. A tilted orientation as usedherein may refer to an arrangement of electrodes that is rotated about15°, 30°, 45°, 60°, 75°, 90°, 120°, 150°, 180° or less clockwise fromthe normal orientation. A tilted orientation as used herein may refer toan arrangement of electrodes that is rotated about 15°, 30°, 45°, 60°,75°, 90°, 120°, 150°, 180° or more counterclockwise from the normalorientation. A tilted orientation as used herein may refer to anarrangement of electrodes that is rotated about 15°, 30°, 45°, 60°, 75°,90°, 120°, 150°, 180° or less counterclockwise from the normalorientation. A tilted orientation as used herein may refer to anarrangement of electrodes that is rotated 15°, 30°, 45°, 60°, 75°, 90°,120°, 150°, or 180° clockwise or counterclockwise from the normalorientation. In some instances, a tilted orientation of electrodes maybe arranged in a diamond shape relative to a longitudinal axis of theuser. Electrodes arranged in a tilted orientation may have a virtualline going through a LA electrode and a RL electrode be substantiallyparallel to a longitudinal axis of the user. Electrodes arranged in atilted orientation may have a virtual line going through a LL and RAelectrode be substantially perpendicular to a longitudinal axis of theuser. Electrodes arranged in a tilted orientation may have a virtualline going through a LL electrode and a RA electrode be substantiallyparallel to a longitudinal axis of the user. Electrodes arranged in atilted orientation may have a virtual line going through a LA and RLelectrode be substantially perpendicular to a longitudinal axis of theuser.

In some instances, a kit for obtaining physiological data may beprovided. The kit may comprise a patch (e.g., as previously describedherein) and instructions regarding a relative placement and orientationof the patch. The instructions may provide a recommended placementand/or orientation of the patch (e.g., as illustrated in FIG. 2). Insome instances, a kit for obtaining physiological data may comprise apatch and instructions regarding at least two different positions andorientations of the patch. The orientation of the patch may depend on arecommended placement (e.g., position) of the patch.

FIG. 3 illustrates a method of collecting physiological information, inaccordance with embodiments. In step 302, a removable layer is removedfrom a base of a patch. The removable layer may be as previouslydescribed herein (e.g., configured to provide protection fromenvironmental factors prior to usage). The removable layer may beremoved by a user of the patch. The removable layer may comprise a tab.The tab may be configured to aid a user in easily removing the removablelayer. In some instances, removable layer may comprise markings toindicate a desired placement and/or orientation of the patch. In someinstances, the tab may be configured to indicate a desired placementand/or orientation of the patch.

In step 304, the patch is placed near a center of a chest of a user,wherein the patch is oriented such that electrodes on the patch arearranged in a preferred orientation relative to a longitudinal axis ofthe user, as previously described herein (e.g., in a normalorientation). Alternatively, the patch is placed near an upper rightchest of a user, wherein the patch is oriented such that electrodes onthe patch are arranged in a preferred orientation relative to alongitudinal axis of the user, as previously described herein (e.g., ina normal orientation).

In step 306, data is collected from the patch. The data may comprisephysiological data regarding the user. The data may comprise ECG data.The data may comprise 6-wave ECG data. The data may comprise heart rateand respiration data. The data may comprise acceleration, hydration,temperature, SpO2, and blood pressure. The data may comprise ambulatorydata. The data may comprise data regarding a motion, location of theuser. The data may comprise auditory, visual, or barometric data of theuser or an environment around the user. In some instances, patch may beused for lead off detection. A lead-off detection may detect whether alead that is supposed to be hooked up is not properly connected (e.g.,to a user, etc). To detect lead-off, an impedance between each of thedifferential-sensing electrodes and a lead-off electrode may bemonitored by the patch. In some instances, this impedance measurementmay additionally provide an input for measurements of respiration rate.

In step 308, the patch is removed. In some instances, the whole patchmay be removed and discarded. In some instances, part of the patch maybe removed and discarded. For example, a base of the patch may beremoved and discarded while an electronic module of the patch may bereused.

The patch may communicate with a clinical monitor (e.g., conventionalECG monitor) and/or any other device for reading and/or interpreting ECGrelated data. The patch may communicate with the clinical monitorthrough a wired connection and/or wireless connection (e.g., radio,wifi, Bluetooth, etc). FIG. 4 illustrates patch 402 in communicationwith clinical monitor 404 via wireless link 406. For example, twowireless devices may be used. The patch (e.g., electronic module) maycomprise a wireless communication device (e.g., radio), as previouslydescribed herein, and the clinical monitor may be fit (e.g., retrofit)with an adaptor 408. The radio may be as previously described herein(e.g., a triple-mode hybrid radio).

The adaptor may be configured to receive data signals (e.g., viawireless link) from one or more patches and output data to the clinicalmonitor which can read and/or interpret the data. In some instances, theradio may send signals one way to the adaptor, and the adaptor may beconfigured to receive the signals, but not communicate back to the patch(e.g., the radio on the patch). In some instances, a communicationscheme between the patch (e.g., the radio on the patch) and the adaptormay be two ways such that the adaptor may receive signals from the patchand send signals back to the patch. For further description regardingwireless communication schemes, please refer to U.S. Pat. Nos. 8,926,509and 9,019,934 which are hereby incorporated by reference in theirentirety.

Instrumentation amplifiers (IA) may be used to amplify signals (e.g.,voltage signals). In some instances, IAs may amplify an input signal(e.g., amplify a single ended input). The IAs may be integrated into thepatch. Alternatively, the IAs may be integrated into the clinicalmonitors. FIG. 5 illustrates a single ended amplification of signal fromelectrodes. Electrode 502, 504, 506, and 508 may correspond each to theRA, LA, RL, and LL electrodes as designated in a conventional ECG. Awireless patch may accomplish lead-off detection for RA, LA, and LL, aspreviously described herein. A wireless patch may acquire the RA, LA,and LL signals and amplify the signals using three different IAs 510,512, 514 as illustrated. The signals may be sent via wireless link aspreviously discussed herein to the adaptor. The signals may be furtherprocessed to generate the lead signals. Acquisition of RA, LA, LLsignals in a single ended manner and reproducing the same at the adaptor(e.g., via wireless link) may have shortcomings. In some instances, dueto being a single ended signal acquisition, the power supply pick up maynot be rejected, and a noise of the signal may be high. Additionally,the number of IAs that are necessary may necessarily correspond to anumber of electrode signals being measured, which may lead to a highdata rate burden on the wireless link.

In some instances, IAs may amplify a difference between two input signalvoltages (e.g., amplify a differential input). The IAs may be integratedinto the patch. Alternatively, the IAs may be integrated into theclinical monitors. FIG. 6 illustrates generation of limb leads usingthree IAs. Electrode 602, 604, 606, and 608 may correspond each to theRA, LA, RL, and LL electrodes as designated in a conventional ECG. Awireless patch may accomplish lead-off detection for RA, LA, and LL, aspreviously described herein. The patch may comprise instrumentationamplifiers (IA) to generate the lead signals (e.g., Lead I, Lead II,Lead III signals). The first IA 610 may generate Lead I by measuring andamplifying difference between a signal from the LA electrode and the RAelectrode. The second IA 612 may generate Lead II by measuring andamplifying difference between a signal from the LL electrode and the RAelectrode. The third IA 614 may generate Lead III by measuring andamplifying difference between a signal from the LL electrode and the LAelectrode. Signal from the RL electrode may be sent to a right leg drive(RLD) 616 for use in noise reduction. Acquisition of signals in adifferential manner may have benefits. For example, noise of signal maybe reduced (e.g., power supply pickup is rejected). Additionally, fewerIAs may be necessary, leading to lower data rate on the wireless link.The patch may contain at least one less IAs than a number of leadsignals to be generated. In some instances, the patch may contain atmost two IAs in order to generate three lead signals (e.g., Lead I, LeadII, and Lead III signals). In some instances, the number of IAs requiredfor generation (e.g., acquisition) of a certain number of lead signalsmay be equal to the number of lead signals, one less than the number oflead signals, or two less than the number of lead signals.

FIG. 7 illustrates acquisition of three lead signals with two IAs, inaccordance with embodiments. Electrodes 702, 704, 706, and 708 maycorrespond each to the RA, LA, RL, and LL electrodes as designated inconventional ECG. A wireless patch may accomplish lead-off detection forRA, LA, and LL, as previously described herein. In some instances, RLlead off detection may result in lead off indication for RA, LA, and LL.The patch may comprise instrumentation amplifiers (IA) to generate thelead signals (e.g., Lead I, Lead II, Lead III signals). The first IA 710may measure and amplify a difference between a signal from the LAelectrode and the LL electrode, referred to as LA*. The second IA 712may measure and amplify a difference between a signal from the RAelectrode and the LL electrode, referred to as RA*. A signal from the RLelectrode may be sent to a right leg drive (RLD) 716 for use in noisereduction. The signals generated and/or amplified by IAs may betransmitted (e.g., via a wireless link) and received at an adaptor.

FIG. 8 illustrates an adaptor 802 for receiving and outputting signalsto ECG monitor 804, in accordance with embodiments. The adaptor maycomprise digital to analog converters (DACs). The DACs may convert datareceived over the wireless link in binary form (e.g., digital data) intoan analog form for output to an ECG monitor. The adaptor may comprise afirst DACs 806 outputting LA*, a second DAC 808 outputting RA*, and athird DAC 810 outputting LL*. LA* and RA* may refer to LA* and RA* asused with respect to FIG. 7. LL* may equal 0. For example, DAC 810 mayhave a constant input in a way such that the output of the DAC is alwaysat zero voltage. LL* equaling 0 may mean that there is no signal levelor that the signal level is always zero volts at all times. The ECGmonitor may process the data in order to calculate limb leads andaugmented limb leads. Using notations used in FIG. 7 limb leads andaugmented limb leads may be calculated according to the followingequations:

Lead I=LA*−RA*=(LA−LL)−(RA−LL)=LA−RA

Lead II=LL*−RA*=0−(RA−LL)=LL−RA

Lead III=LL*−LA*=0−(LA−LL)=LL−LA

aVR=RA*−½(LA*+LL*)=RA−LL−½(LA−LL−0)=RA−½(LA+LL)

aVL=LA*−½(RA*+LL*)=LA−LL−½(RA−LL+O)=LA−½(RA+LL)

aVF=LL*−½(RA*+LA*)=0−½(RA−LL+LA−LL)=LL−½(RA+LA)

Additionally, respiration and pace maker signals may be calculated. Forexample, a user (e.g., a patient) may have a pace maker and a pace makersignal may be present along with ECG signals. The pace maker signal maybe extracted at the patch end and be transmitted (e.g., wirelessly) tothe adaptor. The pace maker signal may be added to ECG signals appliedto monitor inputs. For example, the DACs may output a pace maker signal.In some instances, the third DAC (outputting LL*=0) may output the pacemaker signal. In such a case, Lead I may be free of the pace makersignal but Lead II, Lead III, aVR, aVL, and aVF may comprise the pacemaker signal (e.g., contain LL* as can be seen in the equations above).In some instances, the first DAC (outputting LA*) may output a pacemakersignal and the second DAC (outputting RA*) may output an invertedpacemaker signal. In such a case, all three limb leads and augmentedlimb leads may comprise the pace maker signal. In some instances,respiration may be calculated by injecting a current through ECGelectrodes into a user's body and measuring resistance variations (e.g.,in response to respiration). While measurement of respiration and pacemaker has been described in the context of wireless patches comprisingtwo IAs, any of the patches including wired patches and patchescomprising zero, one, two, three or more IAs may measure the pacemakersignal and respiration.

FIG. 9 illustrates an alternative set up for acquisition of three leadsignals with two IAs, in accordance with embodiments. Electrodes 902,904, 906, and 908 may correspond each to the RA, LA, RL, and LLelectrodes as designated in conventional ECG. A wireless patch mayaccomplish lead-off detection for RA, LA, and LL, as previouslydescribed herein. In some instances, RL lead off detection may result inlead off indication for RA, LA, and LL. The patch may compriseinstrumentation amplifiers (IA) to generate the lead signals (e.g., LeadI, Lead II, Lead III signals). The first IA 910 may measure and amplifya difference between a signal from the LA electrode and the RAelectrode, referred to as LA*. The second IA 912 may measure and amplifya difference between a signal from the RA electrode and the LLelectrode, referred to as RA*. A signal from the RL electrode may besent to a right leg drive (RLD) 916 for use in noise reduction. Thesignals generated and/or amplified by IAs may be transmitted (e.g., viaa wireless link) and received at an adaptor. The adaptor may receive andoutput signals to an ECG monitor, substantially as described withrespect to FIG. 8.

Acquisition of three lead signals via a patch comprising two IAs may beespecially useful for wireless transmission of data. Because a smallnumber of IAs are needed, data rate of a wireless link may be low andpower consumption may be reduced. Additionally, because a small numberof IAs are utilized, more space may be available for additionalcomponents within the patch. As signals are acquired in a differentialmanner (e.g., not single ended), power supply pick up may be rejected.In addition, the configuration may work well for acquisition ofrespiration and pace maker signals, for reasons described above.

In some instances the patch may communicate with one or more otherpatches or electrodes. FIG. 10 illustrates a patch 1002 having a port1004 for connection to an electrode 1006, in accordance withembodiments. The electrode may be attachable (e.g. physicallyattachable) to the patch. The patch may be separable with the electrode.In some instances, the electrode may be removably attachable to thepatch. While FIG. 10 shows one additional electrode to be connected tothe patch, it is to be understood that one, two, three, four, five, six,or more electrodes may be configured to communicate with the patch. Theport 1004 may be configured to be able to connect to any conventionallyavailable electrode. The electrode may be utilized in acquiring otherphysiological data that may complement data acquired by the patch. Forexample, the electrode may be utilized in generating precordial leads,or V signals (e.g., as used in conventional ECG). Patch 1002 may beplaced on a user as previously described herein (e.g., near a center ofthe chest in a specific orientation). Electrode 1006 in communicationwith the patch (e.g., via wires) may be placed on a user as aconventional V-electrode may be placed. Data acquired through the patchand/or the electrode in communication with the patch may be transmittedvia wireless link to an adaptor (e.g., ECG monitor).

FIG. 11 illustrates a patch 1102 connected to an electrode 1104 using awire 1106 acquiring data regarding limb leads, augmented limb leads, andprecordial limb leads. Data acquired at the electrode may be transmittedto the patch using the wire. The electronic module of the patch maygather data acquired by the patch and/or data acquired by externaldevices (e.g., the electrode) in communication with the patch. Thegathered data may be sent to an external device (e.g., adaptor, clinicalmonitor, etc) using a wireless link as previously described herein.Electrodes 1108 illustrate alternative positions the electrodes may beplaced in order to gather information regarding precordial leads. Whilethe patch 1102 is shown connected to one electrode 1104, the patch insome instances, may be connected to any combination of the electrodes1104 and 1108 shown.

The patch may communicate with one or more external devices. The patchmay communicate with the one or more devices through wired connectionsor wireless connections (e.g., radio, wifi, Bluetooth, etc). In someinstances, two wireless devices may be used, one at the patch and one atthe external device. The two wireless devices may form a wireless linkthat can be used for communication. For example, the patch maycommunicate with a clinical monitor (e.g., ECG monitor) as previouslydescribed herein. In some instances, the patch may have both wired andwireless capabilities. For example, the patch may communicate with anelectrode (e.g., for generation of precordial leads) through a physicalconnection (e.g., via wires) and data acquired using the patch and theelectrode may be transmitted using wireless communication. In someinstances, the patch may communicate with a plurality of externaldevices. For example, a wireless device on the patch may be configuredto communicate with a plurality of external devices such as computers,clinical monitors, gadgets, mobile devices (e.g., cell phones), PDAs,tablets, fitness trackers, etc.

In some instances, the patch may be configured to automatically uploaddata from the patch to an external storage medium (e.g., to a computer,cloud storage, memory, etc). In some instances, uploaded data may beautomatically analyzed using one or more processors (e.g., usingcomputer algorithms). Depending on the analysis, an alert may be sent tothe user. For example a visual, auditory, or haptic warning may be sentto a user (e.g., on the patch). For example, a visual, auditory, orhaptic warning may be sent to an external device in communication withthe one or more processors (e.g., cell phone, computer, etc). In someinstances, depending on the analysis, data may be sent to a healthcareprofessional for further analysis. In some instances, the patch may beconfigured to automatically send data from the patch to a healthcareprofessional or a clinical monitor.

FIG. 12 illustrates an open patch platform 1202 communicating with otherdevices, in accordance with embodiments. The open patch platform maycomprise a patch described throughout the application. The patch maycomprise advanced sensors able to gather more data than conventionallyavailable basic sensor 1204. The patch may monitor various physiologicalparameters. For example, the patch may be configured for 6-wave ECGmonitoring. The patch may be configured to collect data regarding threelimb leads and three augmented limb leads. The patch may be configuredto connect to (e.g., physically be coupled to) additional electrodessuch that precordial leads may be generated as well. The patch maymonitor heart rate and respiration of a user, as previously describedherein. In some instances, the patch may monitor acceleration,hydration, temperature, SpO2, blood pressure. The patch may beconfigured for ambulatory monitoring. The patch may monitor a motion,location, audio, video, pressure of the/around the user.

In some instances, gathered data (e.g., using the open patch platform)may be interpreted using an on-board processor (e.g., on the electronicmodule) or an off-board processor such as a processor on external device1206. The interpreted data may be displayed on a display. For example,the interpreted data may be displayed for view on a display of the basicsensor and/or external device. The interpreted data may be used to sendan alert (e.g., to the user or a healthcare professional) or may be sentelsewhere for further processing and/or analysis. In some instances,interpreted data displayed may be data regarding a user's wellness. Insome instances, gathered data may be stored (e.g., on a memory, cloudstorage, etc). The stored data may be sent to a healthcare professionalor be accessed by a healthcare professional for clinical interpretationas needed.

In some instances, different patches may be configured to monitorydifferent physiological parameters. The different patches may be swappedin and out depending on desired a physiological parameter to monitor. Insome instances, a patch may comprise modular components. For example,the patch may comprise a port to which other external devices orcomponents may be connected to. The external devices and/or componentsmay provide additional functionality to the patch. For example, a patchmay be configured for 6-wave ECG monitoring while additional devicesthat are connected to the patch may be configured to monitoracceleration, temperature, and hydration of a user. The additionaldevices may connect to the patch via wired or wireless communication. Insome instances, a single patch may be configured to monitor the variousphysiological parameters.

The patch may be configured to work together with applications (e.g.,computer algorithms). For example, the patch may be capable ofmonitoring various physiological parameters and specific applicationsmay be played (e.g., selected by a user to be executed) in order togather a subset of the physiological parameters. A single applicationmay be executed and a physiological parameter may be selected within theapplication that a user desires to monitor. In some instances, differentapplications may be executed to monitor different physiologicalparameters. Selecting a subset of the various physiological parametersmay save resources on the patch such as power and battery. In someinstances, different applications may be configured to work withdifferent patches (e.g., having different capabilities) and/or differentexternal devices. The applications may be executed on the patch.Alternatively, the applications may be configured to be executed onexternal devices in communication with the patch (e.g., computer,fitness tracker, cell phone, etc).

FIG. 13 illustrates wired and wireless patch systems as previouslydescribed herein. A wireless patch may have high-connection andreliability. A wireless patch may be as reliable or more reliable than awired patch. A wireless patch may be more reliable than a wired patchdue to absence of the wires. A wireless patch may operate wirelessly forup to 10 m, 15 m, 20 m, 25 m, 30 m, 35 m, 40 m, 50 m, 55 m, 60, 70 m, 80m, 90 m, 100 m, or more away from an adaptor as previously describedherein. A wireless patch may be fully disposable. A wireless patch maybe partially disposable. For example, only the electronic module (e.g.,as previously described herein) may be preserved while other componentsare disposed. For example, only the electronic module may be disposed ofwhile other components are preserved. In some instances, the electronicmodule of a wireless patch may be replaced with, or switched out forother electronic modules comprising alternative, and/or additionalfeatures. The other electronic modules may comprise alternative, and/oradditional sensors. A wireless patch may be ultra-low powered. Awireless patch may be cost competitive. A wired monitoring system may beretrofit to enable wireless communication. A wired or wireless patch asdescribed herein may monitor physiological parameters such as ECG,respiration, SpO2, Temperature, Blood Pressure, Hydration, and/orglucose. A wired or wireless patch as described herein may monitormotion, location, pressure, and/or audio (e.g., of a user or environmentaround the patch).

FIG. 14 illustrates a wireless patch/receiver system for patientmonitoring, in accordance with embodiments. The patch may be placed on auser 1402, such as a patient requiring monitoring. The patch may be usedfor lead off detection. The patch may provide lead-off detection to thepatient. The patch may be used to acquire ECG data. The patch mayprovide defibrillation and/or ESD protection. The patch may be used toprovide a RL drive. The patch may be used to detect a pace maker pulse.The patch may be used for respiration measurement, as previouslydescribed herein. The patch may be used to acquire any other datadescribed elsewhere (e.g., SpO2) as necessary. Data acquired by thepatch may be transmitted (e.g., wirelessly) to an adaptor as describedelsewhere. The adaptor may generate data regarding ECG, pace makerpulse, respiration, etc. The generated data may be viewed by the patientor a healthcare professional.

FIG. 15 illustrates a wireless patch/mobile device system, in accordancewith embodiments. The patch may be placed on a user 1502. The user maybe an ordinary user participating in everyday activities, or a sportsrelated activity. The patch may be used for lead off detection. Thepatch may provide lead-off detection to the patient. The patch may beused to acquire ECG data. The patch may provide defibrillation and/orESD protection. The patch may be used to provide a RL drive. The patchmay be used to detect a pace maker pulse. The patch may be used forrespiration measurement. The patch may be used to acquire any other datadescribed elsewhere (e.g., SpO2) as necessary. Data acquired by thepatch may be transmitted (e.g., wirelessly) to a mobile device asdescribed elsewhere. The mobile device may generate data or display dataregarding ECG (e.g., ECG with WCT), lead-off detection, pace maker pulsesignals, etc.

FIG. 16 illustrates electronics for the patch, in accordance withembodiments. The electronics may comprise a plurality of components,such as a coin cell 1602, on/off switch 1604, edge connector 1606,antenna 1608, electrodes (e.g., four point electrodes) 1610,defibrillator protectors 1612, and/or wireless modules 1614. The edgeconnector may comprise a four-wire SPI interface, an external VIOoption, and/or an external VBAT option. The electronics for the patchmay all be integrated within the patch. In some instances, at least apart of the electronics may be located on or within the electronicmodule. The electronic module may comprise a coin cell, on/off switch,edge connector, antenna, electrodes, defibrillator protectors, and/orwireless modules. In some instances, some components of the electronicsmay be located off-board the patch. In some instances, some componentsof the electronics for the patch may be switched out for otherelectronics with different functionalities, as previously describedherein.

FIG. 17 illustrates a wireless module 1702, in accordance withembodiments. The wireless module may enable communication with anexternal device, such as the adaptor or mobile device previouslydescribed herein. The wireless module may comprise a plurality ofcomponents. The wireless module may be in direct communication with anelectronic component of the patch, such as the batter 1704, sensors(e.g., body interfaces) 1706, and/or antennas 1708. The wireless modulemay comprise a flash memory 1710. The flash memory may store (e.g.,temporarily or permanently) acquired data from the patch. The wirelessmodule may comprise a chip, such as a REACH-1D chip 1712. A REACH-1Dchip may intake analog signals and convert it to digital signals. AREACH-1D chip may intake digital signals and convert it to analogsignals. The signals (e.g., digital or analog signals) may betransmitted to an external device or component (e.g., adaptor or mobiledevice) through a wired or wireless connection. In some instances,digital signals may be transmitted via a wireless connection.

FIG. 18 illustrates a patch design, in accordance with embodiments. Insome instances, the patch may be a foldable patch. The patch maycomprise a single substrate with folds. For example, various externalhousing components of the patch may be constructed of a single mold. Forexample, the cover, base, and/or spacer as previously described hereinmay be constructed on a single mold. For example, FIG. 18 shows a base1802, cover 1804, and spacer 1806, 1808, 1810 made of a single mold. Thepatch may comprise a plurality of substrate components that may befolded onto (e.g., on top of) one another. For example, the patch maycomprise substrate components 1802, 1804, 1812, and 1814 that may befolded on top of one another. The plurality of substrate components maybe made of a single mold. Each of the substrate components may beconfigured to support (e.g., receive, house, comprise) differentelectronic components of the patch. In some instances, a substratecomponent may not be configured to support an electronic component,e.g., substrate component 1804. For example, substrate component 1812may be configured to support electrodes, and/or ECG gel cups. Forexample, substrate component 1814 may be configured to support a coinbattery and/or UWB antennas. For example, component 1802 may beconfigured to support a processor or ASIC module. Each of the electroniccomponents may be in communication with one another, e.g., throughconductive traces. The conductive traces may traverse through eachsubstrate components. The conductive traces may traverse through eachsubstrate components comprising or supporting an electronic component.

FIG. 19 illustrates two different perspectives of a blown up view of apatch design, in accordance with embodiments. View 1901 shows theexploded patch viewed from above while view 1903 shows the explodedpatch from viewed from below. The patch may comprise a cover 1902, abase 1904, and a spacer 1906 configured to house electronic module 1908.The electronic module is shown coupled to electrodes 1910, 1912, 1914,and 1916 through intermediary structure 1918. The spacer may be furtherconfigured to be coupled to the cover and the base. The spacer maydefine a space in which the electronic module is to be located in andseparates the base from the cover. The patch may further comprisecutouts 1920 and gels 1922 as previously described herein.

FIG. 20 illustrates a working configuration of the patch design of FIG.19 from two different perspectives, in accordance with embodiments. View2001 shows the patch from above while view 2003 shows the patch frombelow. Electrodes 2010, 2012, 2014, and 2016 can be seen on (e.g.,through) base 2004. The base may comprise the electrodes.

FIG. 21 illustrates a patch design, in accordance with embodiments. Insome instances, the base 2102, spacer 2104, and cover 2106 may beconfigured to be placed on top of the other. The electronic module 2108may be disposed between the base and the cover, within a space definedby the spacer, substantially as described elsewhere.

The patch may be constructed and tested according to the followingexemplary, non-limiting instructions. 1) Obtain 4 inch by 36 inch stripof 1/32″ silicone sheeting. 2) Place the sheeting on the poly cuttingboard. 3) Place the 3.5″ punch over the area, allowing at least ½ inchon all sides. 4) Using the rubber mallet, hit the top of the punch andeach side at least 2 times. 5) Twisting the punch to ensure that thesilicone is cut through, carefully lift the punch and remove the 3.5″circle. 6) Inspect each circle to ensure that there aren't any tears onthe outside or loose tags of silicone. 7) Clean silicone sheet with 70%IPA to ensure all powder is removed from silicone sheet. 8) Using atemplate and sharpies, mark the areas where the snaps will go. FIG. 22illustrates a measurement template that may be used for marking areaswhere snaps will go. Use blue or white for white, black for black, redfor red and green for green. Use a single small dot, just large enoughto see. 9) Gather prong tools: blue prong tool, hammer, and pencil witheraser. 10) Using pencil and a prong snap component, and a depiction(e.g., FIG. 23) insert the prong snap from the underside of the circleso that the dot is centered, using the pencil eraser to poke the prongsthrough the silicone. FIG. 23 illustrates a depiction that may be usedfor inserting a prong snap. 11) Place the prong component, prong side upinto the blue snap tool. Place a snap receptacle component over theprongs into the hole of the tool. 12) Hit the tool twice with a hammer.13) Repeat until all four snaps have been placed. 14) Make siliconerings according to the following: retrieve 1/16″ silicone sheeting, cutinto 4″×36″ strips; clean the silicone with 70% IPA wipes to remove allpowder; on the poly cutting board, using the 3.5″ punch over thesilicone sheeting with at least ½ inch exposed on all sides and therubber mallet, tap the leather punch on all sides of the punch at leasttwice; twist the punch on the silicone to ensure that the silicone iscut through; lift the punch and carefully remove the formed circle; onthe poly cutting board, using the 3″ punch over the 3.5″ siliconecircle, with ¼″ on all sides exposed, tap the punch with the rubbermallet at least twice on all sides; twist the leather punch on thesilicone to ensure that the silicone is cut through; remove the 3″center portion and discard; remove the ring around the outside of thepunch; use three rings for each patch; inspect each ring to ensure thatit has a clear edge and all markings have been removed. 15) Attach ringsto bottom assembly according to the following: turn the patch bottomcomponent snap receptacle side down onto a space suitable for gluing;don gloves; retrieve Loctite 4011 from refrigerator; center cup ontopatch bottom; glue silicone seals to patch bottom; place a small line ofLoctite all around the outside of the cup. Place one silicone seal onthe patch bottom, wiping up any excess glue as you go. Repeat for twomore seals to make a total of 3/16″ sides on the patch. 16) InspectPatch bottom assembly to ensure that they are clean and cosmeticallyacceptable. 17) Add wires to bottom assembly according to the following:cut four one inch pieces of 28 G wire, one for each color: red, black,white and green; solder to ring side of marked snap connectors: red tored, black to black, white to white and green to green; ensure all wiresare soldered; make 3″ wire cover label, using Avery label stock; punch 2mm holes in wire cover label at center position of snaps; holding thewire cover label over the bottom assembly, pull all four wires throughthe prepared holes; remove the adhesive back and firmly affix to bottomof assembly; ensure that all four wires are pulled through and the labelis cosmetically acceptable, evenly placed and without any wrinkles. FIG.24 depicts a first illustration 2402 showing wires soldered to a bottomassembly, a second illustration 2404 showing a wire cover label, and athird illustration 2406 showing the wire cover affixed to the bottomassembly. 18) Add the HMI module to the bottom assembly according to thefollowing: affix the HMI module to the bottom assembly using doublesided foam tape. Ensure that the module antenna (blue) is as far awayfrom the white wire snap connector as possible while the bottom of themodule is as close to the green wire snap connector as possible withoutbeing on top of the snap connector; solder wires from bottom assembly toHMI module; verify that all the connections are solid. FIG. 25illustrates a general view 2502 and detailed view 2504 of wire layout tothe HMI module. 19) Prepare the switch and LED according to thefollowing: short the LED cathode to 2.2K ohm resistor; bring the otherside of the resistor out on a pin header; short the LED anode to pin 2of the button switch and glue the LED to the right side wall of theswitch; bring out a wire from pin 2 of the button switch on a pinheader; bring out a wire from pin 1 of the button switch on a pinheader. 20) Prepare the battery according to the following: add femalepin header to red wire; add female pin header to black wire. 21) Addswitch, led and battery to bottom assembly according to the following:arrange battery and switch on bottom assembly, with the writing onbattery up; glue the LED to the side of the switch, ensuring that theLED still lights up; glue switch using Loctite 4011 to inside wall ofseal ring, equidistant between the white and the black labeledwires/snaps; connect wires; secure battery under wires, bending cornersas needed to fit into the circular bottom assembly; do not glue down thebattery. FIG. 26 illustrates HMI module attached to the bottom assemblyin a first illustration 2602 and switch, led, and battery attached tothe bottom assembly in addition to the HMI module in a secondillustration 2604. The design allows for battery replacement. 22) LoadPatch driver according to the following: change the working directory tosubdirectory “builds;” make sure button switch on Patch in off position;assemble hardware and setup; power on the supply. The LED on the Patchshould glow and current consumption shown on the supply should be within12 mA. If it is showing more than 50 mA, switch of the supply and debug.Make sure polarity of the cable connected from the supply to the adapterboard is correct. From builds directory, execute the appropriatecommands at the Linux prompt. The various hardware and setup necessarymay include FT2232H Mini module (e.g., from Digikey); HIM Module to FTDIadapter (e.g., from Hmicro); Flat 10 finger flex cable (0.5 mm pitch)from Digikey; 3.6V supply; and USB cable—male A type to male Mini Btype. 23) Load Adapter driver according to the following: assemblehardware and setup including adapter board 3.3 Version, dac Adapterboard 2.0 Version, USB cable, and 5V DC wall power supply adapter;ensure jumper settings are; connect the USB cable to the PC from theadapter board; connect the 5V power supply from the board to the walland turn on the power by pressing on the rocker switch; using the linuxPC, from builds directory, execute the appropriate commands at the Linuxprompt. If asked for password, give login password; turn off the adapterboard by toggling the power switch; change the number 3 jumper settingsuch that both switches are moved to the left side; connect the DACadapter board and ECG cable to the monitor; verify adapter board isready to receive signals from the patch and display on the monitor; rRemember to turn on the adapter switch first and then switch on thepatch. 23) Add top and finish Patch according to the following: preparetop using a 3.5″ diameter punch, and punching a circle from 1/32″silicone sheet with adhesive on one side. Make a 5 mm hole at theposition of the yellow button of the switch for the bottom assembly;prepare label using Uline S-19298 labels, print labels using laserprinter and LBL-1008; punch label into 3″ diameter circle; usingprepared, punched top as a template, make a 5 mm hole at the position ofthe punched hole of the top. Ensure that top and label will align withthe switch of the bottom assembly; using the bottom assembly, mark theposition of the LED on the label. Use the 2 mm or similar punch to makea hole in the label for the LED; verify accuracy of prepared materialsby aligning the top and label over the bottom assembly and checking theposition of the punched holes over the switch and the LED. If thematerials don't match, discard and start again; add label to top byremoving the adhesive covering from the label and carefully placing thelabel on the top, moving from one side of the label to the other toprevent any air bubbles. Remove any small air bubbles. If air bubblescannot be removed, replace label; remove the adhesive covering from thetop and place it label side down (adhesive side up) on a table; usingthe backing from the label, cover the adhesive side of the top over thesame position as the label. The effect is to have the silicone top inbetween the label and the label cover. The addition keeps the adhesivefrom sticking to the electronics; without touching the adhesive, placelabeled top onto bottom assembly by first aligning the switch and thenmoving your fingers over the top to apply the top to the rings of thebottom assembly. 24) Final testing according to the following: placeelectrodes into all four snaps and if electrodes do not snap into place,reject the patch; inspect for any cosmetic defects (e.g., if label issmeared, reject, if top and bottom assembly do not align, reject, ifthere is excessive glue visible, reject); using the instructions foruse, verify that the demo patch works (e.g., if the LED does not lightup, reject, if the Patch does not pair with the adapter board, reject,if the ECG waveforms do not appear, reject). 25) Clean and packageaccording to the following: prepare pouch label by using C 025 labelstock and LBL-1006, make a pouch label; place label on pouch, carefullymoving from one side of the pouch to the other and preventing airbubbles; clean Patch bottom and sides using slightly dampened C 006 70%IPA wipes. Do not wipe the label; allow to completely dry; place Patchin labeled pouch. FIG. 27 illustrates a patch label that may be placedon the patch.

The patch may be placed, tested, and used according to the followingnon-limiting instructions. 1) Patch Placement and Removal. a) Skinpreparation: select an appropriate electrode site—either the upper leftchest or center chest. Prepare the site by shaving or clipping any heavyhair. Open one of the prep pads and use light skin abrasion in theselected electrode site for best results. b) Prepare and placePatch—Remove Patch from the pouch. Attach electrodes into snapconnectors, removing the covers from the electrode. Avoid touching thegel of the electrodes or placing them on any surface where they mightstick. With yellow button of Patch towards the head and the buttoncentral and parallel to the long axis of the body, remove the coversfrom the electrodes (if not done already), and firmly press the Patchelectrodes on the prepared site to assure uniform contact. For difficultareas such as hairy sites or contours (chest), use more downwardpressure to increase adhesion. c) When testing is complete, turn off thePatch and remove by peeling away from the skin slowly. 2) Demonstrationof Wireless Function. a) Prepare evaluation board and turn on. Connect 5lead set to monitor cable. Connect leads to evaluation board. White (RA)to RA, green (RL) to RL, black (LA) to LA, and red (LL) to LL. Connectpower cable to board and plug into standard outlet. Turn on theevaluation board by pressing the red rocker switch. Two green LEDs closeto the rocker switch will light up to show that the board is turned on.b) Prepare monitor to receive signals. Turn on the monitor. Adjustsettings as desired. c) Make signal connection. Turn on the Patch on thebody by pressing the yellow button and ensuring that the red LED lightis on while verifying that the yellow button is oriented toward thehead, central and parallel to the long axis of the body and that allelectrodes of the patch remain attached. Once the connection is secured,an LED to the right of the rocker switch will turn yellow-red. This maytake a few seconds. d) The ECG will appear on the monitor. 3) Removal ofthe Patch and Equipment Shut Down. a) Remove Patch. Turn off the Patchby pressing the yellow button on the Patch. Note: this saves the batterylife. Remove the Patch by peeling away from the skin slowly. Carefullyremove the electrodes from the Patch by holding down the snap receptaclewith your thumb and gently pulling the electrode from the receptacle.Note: The Patch may be removed and repositioned on the same personwithout changing electrodes. The electrodes are to be used by only oneperson. Each new person should have a new set of electrodes. Electrodesare disposable in regular trash. b) Shut down equipment. Turn off theevaluation board by pressing the red rocker button and unplugging thepower supply. All LED indications will turn off. Turn off the monitor.4) Cleaning and Reuse. To reuse the Patch, wipe down with 70% IPA wipes,dry and store in the original foil pouch.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

1.-93. (canceled)
 94. A method of collecting physiological datacomprising: providing an integrated patch comprising: a base comprisingtwo or more electrodes configured to gather information; a cover coupledto the base, wherein the cover comprises one or more indicatorsassociated with a preferred placement or orientation of the patch; aradio configured to wirelessly transmit or receive data; and anelectronic module comprising an ASIC housed between the base and thecover; and placing the patch on a user based on the one or moreindicators; and collecting information from the patch.
 95. A method ofamplifying a differential signal between two input signal voltagescomprising: providing a patch comprising a base comprising two or moreelectrodes configured to measure a voltage; a cover coupled to the base;a radio configured to wirelessly transmit or receive data; and anelectronic module comprising: an ASIC housed between the base and thecover; and one or more instrument amplifiers configured to amplify adifference between voltages measured from two different electrodes;measuring a voltage from the two or more electrodes; and amplifying adifference between the measured voltages.
 96. A system for acquiringphysiological signals comprising: a wireless integrated patch; and aninstruction regarding a recommended placement and orientation of thepatch.
 97. The system of claim 96, wherein the recommended placementcomprises at least two different locations on the human body and whereinan orientation of the patch is different depending on the differentlocations. 98.-101. (canceled)